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Pronestyl (Procainamide Hydrochloride) - Summary



The prolonged administration of procainamide often leads to the development of a positive antinuclear antibody (ANA) test, with or without symptoms of a lupus erythematosus-like syndrome. If a positive ANA titer develops, the benefits versus risks of continued procainamide therapy should be assessed.



Procainamide Hydrochloride Tablets USP

Procainamide Hydrochloride Capsules USP

PRONESTYL (procainamide hydrochloride), a Group 1A cardiac antiarrhythmic drug, is p-amino-N-{2-(diethylamino)ethyl}-benzamide monohydrochloride, molecular weight 271.

PRONESTYL (procainamide hydrochloride) is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of PRONESTYL, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.

Initiation of PRONESTYL treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.

Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.

Because procainamide has the potential to produce serious hematological disorders (0.5 percent) particularly leukopenia or agranulocytosis (sometimes fatal), its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment clearly outweigh the risks. (See WARNINGS and Boxed WARNING.)

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Published Studies Related to Pronestyl (Procainamide)

Levofloxacin and ciprofloxacin decrease procainamide and N-acetylprocainamide renal clearances. [2005.04]
Ten healthy adults participated in a randomized, crossover drug interaction study testing procainamide only, procainamide plus levofloxacin, and procainamide plus ciprofloxacin.

Procainamide and survival in ventricular fibrillation out-of-hospital cardiac arrest. [2010.06]
OBJECTIVES: Procainamide is an antiarrhythmic drug of unproven efficacy in cardiac arrest. The association between procainamide and survival from out-of-hospital cardiac arrest was investigated to better determine the drug's potential role in resuscitation... CONCLUSIONS: In this observational study of out-of-hospital VF and pulseless VT arrest, procainamide as second-line antiarrhythmic treatment was not associated with survival in models attempting to best account for confounding. The results suggest that procainamide, as administered in this investigation, does not have a large impact on outcome, but cannot eliminate the possibility of a smaller, clinically relevant effect on survival. (c) 2010 by the Society for Academic Emergency Medicine.

Efficacy of procainamide and lidocaine in terminating sustained monomorphic ventricular tachycardia. [2010.05]
CONCLUSIONS: Procainamide, the relatively older drug, was more effective than lidocaine in terminating SMVT associated with structural heart diseases. This is a retrospective analysis but can form the basis for formulating guidelines for initial management of SMVT.

Amiodarone versus procainamide for the acute treatment of recurrent supraventricular tachycardia in pediatric patients. [2010.04.01]
CONCLUSIONS: In this cohort, procainamide achieved greater success compared with amiodarone in the management of recurrent SVT without statistically significant differences in adverse event frequency.

Layered bionanocomposites as carrier for procainamide. [2010.03.30]
The study deals with the intercalation of procainamide hydrochloride (PA), an antiarrythmia drug in montmorillonite (MMT), as a new drug delivery device. Optimum intercalation of PA molecules within the interlayer space of MMT was achieved by means of different reaction conditions...

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Clinical Trials Related to Pronestyl (Procainamide)

Sexual and Urological Rehabilitation to Men Operated for Prostate Cancer and Their Partners [Recruiting]
Today prostate cancer (PC) treatment with curative intent is primarily surgical removal of the prostate gland (prostatectomy) which may be associated with immediate and long lasting erectile dysfunction and decline in urinary function. Besides these physical late effects patients operated for PC have a twofold increased risk for depression up to ten years after the diagnosis. To reduce these late effects affecting both patient and partner the investigators have developed a sexual and urological intervention (PROCAN). The intervention is based on epidemiological data, evidence from previous clinical trials, a feasibility study and qualitative explorations among PC patients and partners. The investigators hereby suggest the conduction of a randomized controlled trial to test the effect of the PROCAN intervention on urological and sexual dysfunction, couples adjustment and quality of life. Results of the proposed trial may provide clinicians and decision makers with the evidence needed to optimize rehabilitation after PC.

Certain People With Atrial Fibrillation May Have Changes on Ecg When Given Procainamide That May be Related to a Genetic Difference [Recruiting]
The purpose of this study is to look for a similarity in people's genes that may help understand which people could benefit from certain drugs for the treatment of atrial fibrillation.

Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia [Recruiting]
The purpose of this study is to determine whether intravenous amiodarone has less cardiac significant adverse events compared to intravenous procainamide in the acute treatment of haemodynamically well tolerated wide QRS tachycardia, the majority of them of probably ventricular origen.

Chemical vs Electrical Cardioversion for Emergency Department Patients With Acute Atrial Fibrillation [Completed]
Atrial fibrillation (AF) is the most common type of irregular heartbeat in emergency department (ED) patients. If the irregular heartbeat has been present for less than 48 hours, there is a chance that emergency treatment can convert the heartbeat into normal rhythm. There are currently two options for accomplishing this; both are widely and safely used in EDs. Each has its advantages and disadvantages. This study will compare the two methods. (1) Patients are given an intravenous medication called procainamide; this converts patients into a normal heart rhythm around 50% of the time. (2) Patients are sedated (put to sleep with a general anesthetic) for about ten minutes, while an electrical current is conducted across the chest; this converts patients into a normal heart rhythm around 90% of the time. Procainamide can cause low blood pressure in about 10% of patients; this is usually corrected by administering intravenous fluids. Sedation can cause low blood pressure in about 10% of patients, and breathing trouble in about 10% of patients; this is usually corrected by administering intravenous fluids, and administering more oxygen, respectively. In thousands of patients studied around the world, there does not appear to have been a reported stroke or death as a result of these procedures. A physician will choose one method, but if it fails, will move to the next method. There are thus two options. (1) Chemical conversion, followed by electrical conversion; and (2) Electrical cardioversion, followed by chemical cardioversion. These options both have a 90%+ chance of converting AF into a normal heart rhythm. However, the investigators believe that an electrical-chemical sequence will be faster than a chemical-electrical sequence, while both will be equally safe. If patients agree to take part in the study, they will be randomized to one of the two options. They will have their breathing, oxygen levels, blood pressure, and heartbeat monitored for their entire ED stay. The investigators plan to enrol 86 patients at five hospitals over the course of about one year. The primary outcome of ED length-of-stay, as well as secondary outcomes, such as conversion to normal rhythm, and adverse events (such as trouble breathing or low blood pressure) will be documented. In addition, an investigator will contact you at three and thirty days after your visit to make sure that there are no problems. Importantly, although the principal and site investigators will be aware of the primary outcome, attending emergency physicians who actually provide patient care will NOT be aware of the primary outcome--otherwise this could bias patient management. When the study is finished, the results will be given to the writing committee merely as the "A" and "B" arms, and not specified as either the "chemical-first" or "electrical-first" arms. The writing committee will compose two manuscripts, (1) assuming that "A" is the "chemical-first" arm and "B" the "electrical-first" arm, and (2) assuming that "A" is the "electrical-first"arm, and "B" the "chemical-first" arm. After both manuscripts have been approved by all authors, the blinding will be removed and only the correct manuscript submitted for publication.

Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias [Completed]
The study evaluates 3 different populations: It is an open, randomized, parallel-group study comparing the effectiveness of intravenous (iv) ajmaline with currently used antiarrhythmic drugs in the acute treatment of : 1. recent-onset atrial fibrillation versus iv flecainide 2. sustained monomorphous ventricular tachycardia versus iv procainamide The study also evaluates in an open, randomized, crossover study, the use of iv ajmaline versus iv flecainide in the diagnosis of Brugada syndrome

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Page last updated: 2011-12-09

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